Tylenol® Extra Strength

SPL v1

SPL

SPL Set ID 3f653262-b931-7d42-e063-6394a90adddd

Route

ORAL

Published

Effective Date 2025-09-22

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (500 mg)

Inactive Ingredients

Crospovidone, Unspecified Stearic Acid Titanium Dioxide Povidone Magnesium Stearate Sodium Starch Glycolate Type A Propylene Glycol Carnauba Wax Fd&c Red No. 40 Hypromellose, Unspecified Microcrystalline Cellulose

Identifiers & Packaging

Pill Appearance

Imprint: TYLENOL;500 Shape: oval Color: white Size: 18 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-10-13

Description

Drug Facts

Purpose

Purpose Pain reliever/fever reducer

Medication Information

Warnings and Precautions

Warnings

Purpose

Purpose

Pain reliever/fever reducer

Description

Drug Facts

Uses

■ temporarily relieves minor aches and pains due to:

- the common col

- headache

- backache

- minor pain of arthritis

- toothach

- muscular aches

- premenstrual and menstrual cramps

■ temporarily reduces fever

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if

■ pain gets worse or lasts more than 10 days

■ fever gets worse or lasts more than 3 days

■ new symptoms occur

■ redness or swelling is present

These could be signs of a serious condition.

Section 50568-5

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Section 50569-3

Ask a doctor before use if you have liver disease

Section 50570-1

■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

■ if you are allergic to acetaminophen or any of the inactive ingredients in this product

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55106-9

Active ingredient (in each caplet)

Acetaminophen 500 mg

Directions

■ do not take more than directed (see overdose warning)

adults andchildren 12 years and over	■ take 2 caplets every 6 hours while symptoms last ■ do not take more than 6 caplets in 24 hours, unless directed by a doctor ■ do not use for more than 10 days unless directed by a doctor
children under 12 years	ask a doctor

Allergy Alert

acetaminophen may cause severe skin reactions. Symptoms may include:

■ skin reddening ■ blisters ■ rash

If a skin reaction occurs, stop use and seek medical help right away.

Liver Warning

This product contains acetaminophen.Severe liver damage may occur if you take

■ more than 4,000 mg of acetaminophen in 24 hours

■ with other drugs containing acetaminophen

■ 3 or more alcoholic drinks every day while using this product

Overdose Warning

In case of overdose, get medical help or contact a Poison Control Center right away.

(1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice

any signs or symptoms.

Other Information

■ store between 20-25°C (68-77°F)

■ do not use if carton is opened. Do not use if foil inner seal imprinted with “TYLENOL” is broken or missing

Inactive Ingredients

carnauba wax, crospovidone, FD&C red no. 40, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium starch glycolate, stearic acid, titanium dioxide

Questions Or Comments?

call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

Prinicipal Dispaly Panel

NDC 50580-108-25

TYLENOL ^®

FOR ADULTS

Acetaminophen

Pain Reliever

Fever Reducer

Extra Strength

Actual Size

225 Caplets

500 mg each

Structured Label Content

Uses

■ temporarily relieves minor aches and pains due to:

- the common col

- headache

- backache

- minor pain of arthritis

- toothach

- muscular aches

- premenstrual and menstrual cramps

■ temporarily reduces fever

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Section 50569-3 (50569-3)

Ask a doctor before use if you have liver disease

Section 50570-1 (50570-1)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55106-9 (55106-9)

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Purpose

Pain reliever/fever reducer

Directions

■ do not take more than directed (see overdose warning)

adults andchildren 12 years and over	■ take 2 caplets every 6 hours while symptoms last ■ do not take more than 6 caplets in 24 hours, unless directed by a doctor ■ do not use for more than 10 days unless directed by a doctor
children under 12 years	ask a doctor

Allergy Alert (Allergy alert)

acetaminophen may cause severe skin reactions. Symptoms may include:

■ skin reddening ■ blisters ■ rash

If a skin reaction occurs, stop use and seek medical help right away.

Liver Warning (Liver warning)

Overdose Warning (Overdose warning)

Other Information (Other information)

■ store between 20-25°C (68-77°F)

■ do not use if carton is opened. Do not use if foil inner seal imprinted with “TYLENOL” is broken or missing

Inactive Ingredients (Inactive ingredients)

Questions Or Comments? (Questions or comments?)

call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

Prinicipal Dispaly Panel (PRINICIPAL DISPALY PANEL)

NDC 50580-108-25

TYLENOL ^®

FOR ADULTS

Acetaminophen

Pain Reliever

Fever Reducer

Extra Strength

Actual Size

225 Caplets

500 mg each

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "■ temporarily relieves minor aches and pains due to: - the common col - headache - backache - minor pain of arthritis - toothach - muscular aches - premenstrual and menstrual cramps ■ temporarily reduces fever", "34071-1": "Warnings", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children.", "50566-9": "Stop use and ask a doctor i f ■ pain gets worse or lasts more than 10 days ■ fever gets worse or lasts more than 3 days ■ new symptoms occur ■ redness or swelling is present These could be signs of a serious condition.", "50568-5": "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin", "50569-3": "Ask a doctor before use if you have liver disease", "50570-1": "■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ■ if you are allergic to acetaminophen or any of the inactive ingredients in this product", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55106-9": "Active ingredient (in each caplet) Acetaminophen 500 mg", "Purpose": "Purpose Pain reliever/fever reducer", "Directions": "■ do not take more than directed (see overdose warning) adults andchildren 12 years and over ■ take 2 caplets every 6 hours while symptoms last ■ do not take more than 6 caplets in 24 hours, unless directed by a doctor ■ do not use for more than 10 days unless directed by a doctor children under 12 years ask a doctor", "Allergy alert": "acetaminophen may cause severe skin reactions. Symptoms may include: ■ skin reddening ■ blisters ■ rash If a skin reaction occurs, stop use and seek medical help right away.", "Liver warning": "This product contains acetaminophen.Severe liver damage may occur if you take ■ more than 4,000 mg of acetaminophen in 24 hours ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks every day while using this product", "Overdose warning": "In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "Other information": "■ store between 20-25°C (68-77°F) ■ do not use if carton is opened. Do not use if foil inner seal imprinted with “TYLENOL” is broken or missing", "Inactive ingredients": "carnauba wax, crospovidone, FD&C red no. 40, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium starch glycolate, stearic acid, titanium dioxide", "Questions or comments?": "call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)", "PRINICIPAL DISPALY PANEL": "NDC 50580-108-25 TYLENOL ® FOR ADULTS Acetaminophen Pain Reliever Fever Reducer Extra Strength Actual Size 225 Caplets 500 mg each"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:41.289658 · Updated: 2026-03-14T23:13:00.870746